Medtronic, Inc. Receives FDA Approval For InterStim(R) II System For Treatment Of Overactive Bladder, Urinary Retention
InterStim Therapy for Urinary Control uses sacral nerve stimulation to improve bladder function. Originally approved by the FDA in 1997, it is indicated in the United States for the treatment of non-obstructive urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, when more conservative treatments fail or cause intolerable side-effects.
The new system also recently received regulatory approval (CE Mark) in Europe, where InterStim Therapy is indicated for the management of chronic intractable (functional) disorders of the pelvis and lower urinary tract or intestinal tract, including overactive bladder, urinary retention, fecal incontinence, and constipation.
The InterStim II system adds a new implantable neurostimulator (INS), a new improved patient programmer and upgraded software for the clinician programmer. These advancements offer a choice of neurostimulation devices to accommodate more patients, streamline the implant procedure, and simplify programming and follow-up care. The improved patient programmer also gives patients more control of their therapy.
"This new smaller, lighter device - combined with the array of smart design changes to other components of the implantable system - will make InterStim Therapy more attractive to both physicians and patients," said Dr. Steven W. Siegel, director of Metropolitan Urologic Specialists' Center for Continence Care in St. Paul, Minn. "The new patient programmer and physician programmer software upgrade represent a significant step forward for this treatment option for overactive bladder and urinary retention. With all of these enhancements, InterStim Therapy deserves a fresh look from physicians and patients alike."
The InterStim II system consists of:
InterStim II Implantable Neurostimulator (INS). Ideally suited for patients with lower energy requirements (as determined during the therapy trial) or smaller bodies, the InterStim II INS is nearly 50 percent smaller by displaced volume and nearly 50 percent lighter by weight than the original device - the InterStim INS, which continues to be available.
InterStim iCon(TM) Patient Programmer. The InterStim iCon Patient Programmer offers many new features to improve patient management for physicians and provide greater therapy control for patients. Patients can use their InterStim iCon programmer to select from four available programs and adjust the stimulation amplitude (only) for each of them. The InterStim iCon programmer offers these new programming features to patients and physicians, regardless of whether they are using the original InterStim INS or the new InterStim II INS.
N'Vision® Clinician Programmer. The N'Vision clinician programmer works with all Medtronic neuromodulation therapies. The new software allows the physician to design and track the utilization of up to four stimulation programs for patients equipped with the InterStim iCon patient programmer. When coupled with the InterStim iCon programmer, the new InterStim software enables improved clinical management of patient therapy.
Overactive bladder affects 33 million people in the United States alone. Worldwide, more than 25,000 people have been treated with InterStim Therapy.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
Contact: Medtronic, Inc., Minneapolis Investor Relations: Jeff Warren, 763-505-2696 or Public Relations: Joe McGrath, 763-505-0291
Source: Medtronic, Inc.